CAJ | 학술논문

目的：比较静脉溶栓治疗急性脑梗死患者在二级医院与三级医院的安全性和疗效。方法前瞻性连续纳入1家二级甲等医院（北京丰台医院）2012年1月-2013年12月使用阿替普酶静脉溶栓治疗脑梗死21例，以1家三级甲等教学医院（首都医科大学宣武医院）同期收治的使用同样药物静脉溶栓65例为对照组，比较两组患者静脉溶栓安全性及疗效指标的差异。主要安全性指标为溶栓后严重不良事件（症状性脑出血和死亡）发生率，主要疗效指标为发病14 d的日常生活能力指数（BI）和出院时的改良Rankin评分（mRS）。结果（1）主要终点指标中，研究组和对照组患者出院时mRS≤2分的比率分别为71.4％（15例）和58.5％（38例）；溶栓后14 d BI≥60分的比率分别为61.9％（13例）和64.6％（42例），两组差异均无统计学意义（P＞0.05）。（2）研究组和对照组的主要严重不良事件发生率为4.8％（1例）和6.2％（4例），差异无统计学意义（P＞0.05）；其他次要指标，如早期再灌注率、血管再通率、溶栓后14 d神经功能改善比率和脑出血发生率差异均无统计学意义。研究组的患者转诊比率（9.5％，2例）低于对照组（27.7％，18例），但差异无统计学意义（P＝0.09）。（3）研究组和对照组的院外时间延误、院内时间延误和总体时间延误，平均时间分别为（75±33）和（102±50）min、（72±41）和（111±38）min、（147±41）和（212±47）min，差异均有统计学意义（P＜0.01）。结论该选择的二级医院可相对安全有效地实施急性脑梗死的阿替普酶静脉溶栓治疗，同时二级医院的静脉溶栓治疗可以减少患者转诊比率和缩短就诊时间。
목적：비교정맥용전치료급성뇌경사환자재이급의원여삼급의원적안전성화료효。방법전첨성련속납입1가이급갑등의원（북경봉태의원）2012년1월-2013년12월사용아체보매정맥용전치료뇌경사21례，이1가삼급갑등교학의원（수도의과대학선무의원）동기수치적사용동양약물정맥용전65례위대조조，비교량조환자정맥용전안전성급료효지표적차이。주요안전성지표위용전후엄중불량사건（증상성뇌출혈화사망）발생솔，주요료효지표위발병14 d적일상생활능력지수（BI）화출원시적개량Rankin평분（mRS）。결과（1）주요종점지표중，연구조화대조조환자출원시mRS≤2분적비솔분별위71.4％（15례）화58.5％（38례）；용전후14 d BI≥60분적비솔분별위61.9％（13례）화64.6％（42례），량조차이균무통계학의의（P＞0.05）。（2）연구조화대조조적주요엄중불량사건발생솔위4.8％（1례）화6.2％（4례），차이무통계학의의（P＞0.05）；기타차요지표，여조기재관주솔、혈관재통솔、용전후14 d신경공능개선비솔화뇌출혈발생솔차이균무통계학의의。연구조적환자전진비솔（9.5％，2례）저우대조조（27.7％，18례），단차이무통계학의의（P＝0.09）。（3）연구조화대조조적원외시간연오、원내시간연오화총체시간연오，평균시간분별위（75±33）화（102±50）min、（72±41）화（111±38）min、（147±41）화（212±47）min，차이균유통계학의의（P＜0.01）。결론해선택적이급의원가상대안전유효지실시급성뇌경사적아체보매정맥용전치료，동시이급의원적정맥용전치료가이감소환자전진비솔화축단취진시간。
Objective To compare the safety and efficacy of intravenous thrombolysis for patients with acute cerebral infarction in a second-grand class-A hospital and a third-grand class-A hospital. Methods Twenty-one consecutive patients with cerebral infarction treated with alteplase for intravenous thrombolysis were enrolled in a second-grand class-A hospital (Fengtai Hospital,Beijing)prospectively from January 2012 to December 2013 as the study group,and 65 patients in a third-grand class-A teaching hospital (Xuanwu Hospital,Capital Medical University,Beijing)admitted at the same period for intravenous thrombolysis were used as a control group. The differences of efficacy and safety of intravenous thrombolysis in patients of both groups were compared. The primary outcome measures were Barthel Index (BI)at day14 after onset and the modified Rankin Scale (mRS)scores at discharge. The main safety indicator was the incidence of serious adverse events (SAEs)after thrombolysis (symptomatic intracranial hemorrhage and death). Results (1 )In the primary outcome measures,the proportions of mRS≤2 at discharge in the study group and the control group were 71. 4%(n=15)and 58. 5%(n=38)respectively. At day 14 after thrombolysis,the proportions of BI ≥60 were 61. 9%(n=13)and 64. 6%(n=42)respectively. There were no significant differences between the two groups (P>0. 05). (2)The incidences of the primary serious adverse events were 4. 8%(n=1)and 6. 2%(n=4). There was no significant difference (P>0. 05). Other secondary outcome measures,such as the early reperfusion rate,recanalization rate,and the proportion of neurological improvement at day 14 after thrombolysis and the overall incidence of cerebral hemorrhage had no significant differences. The case referral proportion (9. 5%,n=2)of the study group had a trend of lowering than the control group (27. 7%,n=18)P=0. 09. (3)The out-hospital time delay, in-hospital time delay,and overall time delay of the study group were less than those of the control group, and the mean time was 75 ± 33 vs. 102 ± 50 min,and 72 ± 41 vs. 111 ± 38 min,147 ± 41 vs. 212 ± 47 min. There were significant differences (P<0. 01). Conclusion The second-grand hospital selected by our study can relatively safely and effectively perform intravenous thrombolysis for acute cerebral infarction with alteplase. Moreover,the intravenous thrombolysis of the second-grand hospitals may reduce the case referral ratio and visiting time.